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Poop pills could tame rare liver disease

NCT ID NCT07477782

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether fecal microbiota transplantation (FMT) can improve liver function in people with primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD). 72 participants will receive either FMT or a sham procedure via colonoscopy and later oral capsules. The main goal is to lower certain liver enzymes and bilirubin levels after 48 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fecal microbiota transplantation (FMT)
What this could lead to
If successful, FMT could offer a new way to control PSC and reduce the need for liver transplants.
What could go wrong
This is an early phase 2 trial with only 72 people. The treatment may not work, and there are risks from the colonoscopy and oral capsules.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males or females * Age ≥18 and ≤75 years * Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC * IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs) * IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment) * ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol/l (with concomitant elevated direct bilirubin). * Treatment with UDCA (13-23 mg/kg/d) for at least 6 months and at the same dosage for at least 3 months * Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly. * Written informed consent signed * Subject affiliated to the French * Social Security System Exclusion Criteria: * Small duct PSC * Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT \> 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG \> 1.5 ULN * Secondary sclerosing cholangitis (notably IgG4-associated cholangitis) * Cirrhosis defined by Liver elastometry \>14.4 kPa or by current or past decompensation of cirrhosis * AST or ALT \> 7 ULN in the last 3 months * Platelets count in the last 3 months \< 100 000/mm3 * Albumin in the last 3 months \<35g/L * Prothrombin index in the last 3 months \< 70% * Hepatic comorbidity: HBV infection (defined by positive Ag HBS), HCV infection (defined by positive HCV RNA), alcohol abuse (defined by alcohol intake \> 30g/day), metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, Hemochromatosis, Wilson disease, α1-antitrypsin deficiency, celiac disease * History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis * HIV infection * Prior liver transplantation * Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date * History of or established or suspected hepatobiliary carcinoma. * Any severe comorbidity that may reduce life expectancy * History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to inclusion) * Dosage changes of treatment for liver disease in the last 3 months or new treatment for liver disease started in the last 3 months * History of colorectal carcinoma or high-grade dypsplasia in previous screening colonoscopy * History of total colectomy * Current active IBD defined by a partial Mayo score \> 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn's Disease Activity Index (CDAI) \> 150 in patients with Crohn's disease * Changes in IBD treatment or initiation of a new treatment for IBD in the last 3 months * Current treatment with biologics (anti-TNF agent, vedolizumab, ustekinumab) or JAK inhibitors (tofacitinnib) or prednisone \> 10 mg/day or budesonide \> 3 mg /day) (or treatment initiated less than one month) * Any contra-indication to swallow capsules * Renal insufficiency (clearance\<60 ml/min) * Unable to consent, subject to legal or administrative decision (protection measure or deprivation of liberty) or involuntary psychiatric care. * Participation in another interventional research without prior consultation with the investigator responsible for the patient's monitoring in the present study (participation in other non-interventional studies is permitted) * Pregnancy or desire for pregnancy or breastfeeding Randomization criteria * No pregnancy (or desire for in the next year) * No other hepatic pathology: HBV (positive HBs Ag), HCV (positive HCV antibody and positive PCR), autoimmune hepatitis * No HIV infection (positive serology HIV1+2 antibodies) * No documented Clostridium difficile infection at inclusion or \< 10 days preceding randomization (in case of infection discovered at inclusion) * No treatment with antibiotics, antifungics or probiotics \< 4 weeks. * Available FMT with EBV and CMV compatibility

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hepatology Department, Saint Antoine Hospital

    Paris, 75012, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.